Opioid-use DisorderNCT04948307
OXD01 in Combination With Sublingual Buprenorphine/Naloxone for Treatment of Opioid Use Disorder
A study testing OXD01 digital therapy in people with Opioid-use Disorder, run by Orexo AB at 21 sites in United States.
Trial summary
This is an open-label, randomized, parallel-group multicenter study designed to evaluate the efficacy of the digital therapeutic OXD01 (MODIA) combined with sublingual buprenorphine/naloxone standard of care (SL BUP/NAL SOC) background therapy compared to SL BUP/NAL alone to change opioid use patterns in subjects with… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Opioid-use Disorder
- What is being tested?
- OXD01 digital therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 437 participants
- Where
- 21 sitesUnited States
- Study dates
- 30 Jun 2021to 10 May 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female 18 - 65 years of age at the screening visit, fluent in English and able to read, comprehend, and willingly sign the informed consent form (ICF).
- Voluntarily seeking treatment for OUD.
- In the judgment of the Investigator has the appropriate hearing, vision, manual dexterity, ability to understand instructions, and ability to use and understand internet-based applications.
- Currently meets the criteria for moderate or severe opioid use disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM)-V (Appendix B).
- Has a positive UDS for opioids at screening that is consistent with their drug use history.
- In good health as determined by lack of clinically significant abnormalities in health assessments performed at screening.
- Agrees not to take any buprenorphine products other than those prescribed by the Investigator during participation in the study, and agrees to use OXD01 as directed if randomized to that treatment group.
- Completed SL BUP/NAL induction, with physical withdrawal symptoms reduced so the subject is able to fulling participate in OXD01 training, if randomized to that treatment group, and is no greater than 14 days from the first dose of SL BUP/NAL induction.
Who cannot join
- 1. Unwilling or unable to comply with the requirements of the protocol or are in a situation or condition that, in the opinion of an Investigator, may interfere with participation in the study (e.g., does not have reliable internet access).
- 2. History of allergy or sensitivity to naloxone, buprenorphine or other opioids, or history of any drug hypersensitivity or intolerance which, in the opinion of an Investigator, would compromise the safety of the subject.
- 3. Used an investigational drug within 30 days or 5 half-lives (whichever is greater) prior to randomization.
- 4. Received prescribed medication-assisted treatment with buprenorphine, methadone, or naltrexone for opioid use disorder within 14 days prior to screening.
- 5. Past or present diseases that, judged by an Investigator and based on available medical history/records, may jeopardize the safety of the subject or impact the validity of the study results.
- 6. Tongue piercing, or piercings in the mouth or oral deformities that may affect sublingual absorption, in the opinion of an Investigator.
Show all 14Show fewer
- 7. Hospitalization for a psychiatric disorder in the past 30 days, not including inpatient treatment for drug rehabilitation.
- 8. Schizophrenia, or other serious mental illness defined as a mental, behavioral, or emotional disorder resulting in serious functional impairment which substantially interferes with or limits participation in the study.
- 9. A Quick Inventory of Depression Symptoms - Self-Report (QIDS-SR, Appendix C) score ≥ 16 (severe depression) or a rating of 2 or 3 for question 12 (Thoughts of Death or Suicide) at screening.
- 10. A current diagnosis, other than opioid use disorder, requiring chronic opioid treatment.
- 11. Chronic pain that is unremitting or unstable. 12. Current DSM-V diagnosis of moderate to severe substance use disorder for psychoactive substances other than opioids, caffeine, marijuana, or nicotine.
- 13. Requires current use of medications that are strong inhibitors or inducers of cytochrome P450 (CYP) 3A4 (Section 4.3.1).
- 14. Any pending legal action that could affect participation or compliance in the trial.
- 15. Is an employee of the Investigator or the trial site, with direct involvement in the proposed trial or other trials under the direction of the Investigator or trial site, or is a family member of the Investigator or an employee.
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
Parkway Medical Center
Birmingham, Alabama, 35215
Midwest Clinical Research Center
Dayton, Ohio, 45417
Patient First Medical Clinic
Dearborn, Michigan, 48126
Otrimed Clinical Research
Edgewood, Kentucky, 41017
Precise Research Centers
Flowood, Mississippi, 39232
Southern Illinois Associates LLC
Glen Carbon, Illinois, 62034
Thalia Medical Center
Haverford, Pennsylvania, 19041
MD Medical Management
Kingston, Pennsylvania, 18704
North Star Medical Research
Middleburg Heights, Ohio, 44130
Neuro-Behavioral Clinical Research Center
North Canton, Ohio, 44720
North County Clinical Research
Oceanside, California, 92054
Pahl Pharmaceuticals Professions
Oklahoma City, Oklahoma, 73112
Aspen Clinical Research
Orem, Utah, 84058
Humanity Clinical Research
Pembroke Pines, Florida, 33024
Medically Assisted Recovery Service
Philadelphia, Pennsylvania, 19116
Institute of Addiction Medicine
Plymouth Meeting, Pennsylvania, 19462
Artemis Institute for Clinical Research
San Diego, California, 92103
Wetlin Research Associates, Inc
San Diego, California, 92120
PsychCare Consultants Research
St Louis, Missouri, 63128
Dr. Vando Medical Services PC
The Bronx, New York, 10466
CincyScience
West Chester, Ohio, 45069
About this study
Official title: A Randomized, Open-label, Parallel-group Study to Evaluate the Efficacy of the Digital Therapeutic OXD01 (MODIA™) in Combination With Sublingual Buprenorphine/Naloxone for the Treatment of Opioid Use Disorder
This is an open-label, randomized, parallel-group multicenter study designed to evaluate the efficacy of the digital therapeutic OXD01 (MODIA) combined with sublingual buprenorphine/naloxone standard of care (SL BUP/NAL SOC) background therapy compared to SL BUP/NAL alone to change opioid use patterns in subjects with opioid use disorder (OUD).
Approximately 400 subjects will be randomized. The study will include a screening visit and a randomization visit, followed by 24 weeks of study treatment. Subjects will be scheduled for evaluation visits, which will include a urine drug screen (UDS) and a self-report of drug use, weekly during the first four weeks of treatment, then every other week from weeks 5 through 12, then monthly through week 25. Subjects will also return to the site for only a UDS and a self-report of drug use each week between the evaluation visits.
The primary objective of the study is to determine whether the combination of sublingual (SL) buprenorphine/naloxone (BUP/NAL) standard of care (SOC) background therapy and the digital therapeutic OXD01 is superior to SL BUP/NAL alone to reduce opioid use.
Read the detailed description
Medication-assisted treatment, the current standard for opioid addiction, is the use of medications in combination with counseling and behavioral therapies to provide a "whole-patient" approach to the treatment of OUD. However, patients may not have optimal access to face-to-face clinical behavioral health services. Digital therapeutics can help bridge the gap between accessible services and optimal treatment of OUD, the primary goal of which is to reduce the use of opioids. OXD01 is a device-based digital therapeutic, designed to offer individuals diagnosed with OUD quality psychotherapy intervention based on cognitive behavioral therapy and motivational interviewing. This study is being conducted to determine the value of OXD01 when combined with medication to change opioid use patterns in subjects with OUD.
Note: No investigational product will be administered as part of this study.
- Conditions
- Opioid-use Disorder
- Being tested
- OXD01 digital therapy, Standard of Care
- Keywords
- digital therapy, cognitive behavioral therapy (CBT)
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OXD01 digital therapyDevice
OXD01 digital therapy, 1-2 times per week 15-30 minutes each time.
Standard of CareOther
Sublingual buprenorphine/naloxone Medication-assisted treatment, the current standard for opioid addiction; the use of medications in combination with counseling
| Study group | Role | What they receive |
|---|---|---|
| Sublingual buprenorphine/naloxone (SL BUP/NAL) standard of care (SOC) background therapy | Other | Standard of care. Subjects in both groups will receive the assigned treatment for 24 weeks. Subjects in both groups may also be encouraged to participate in behavioral health therapies in accordance with the Investigator's standard of practice. Receives: Other: Standard of Care |
| Sublingual buprenorphine/naloxone (SL BUP/NAL) + OXD01 | Experimental | Standard of care + OXD01 (digital therapy). Subjects in both groups will receive the assigned treatment for 24 weeks. Subjects in both groups may also be encouraged to participate in behavioral health therapies in accordance with the Investigator's standard of practice. Receives: Device: OXD01 digital therapy; Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Success Rate
The primary objective was to determine whether the combination of sublingual buprenorphine/naloxone (SL BUP/NAL) and OXD01 was superior to SL BUP/NAL alone to reduce opioid use, measured by the treatment success rate. Treatment success was defined as the subject having >/=80% of urine drug tests negative for opioids plus >/=80% of self-reports negative for illicit opioid use from Week 6 to Week 25. Each subject was evaluated as a success or failure for this metric. The percentage of subjects in each group demonstrating treatment success was tested using the Chi-square test.
If the subject withdrew from the study, the urine drug tests and self-reports for illicit opioid use for all visits after withdrawal were imputed as positive. If the subject completed the study with missing visits, the missing urine drug tests and self-reports for illicit opioids were imputed as positive.
Measured: Week 6 to Week 25
Secondary outcomes (13)
Cumulative Response Rate
The cumulative response rate was calculated from Week 6 to Week 25 of treatment. Response was defined as the presence of both a negative urine drug test for opioids and a negative self-report for illicit use of opioids at a study visit. The cumulative response rate from Week 6 to Week 25 is calculated by dividing the number of responses from Week 6 to Week 25 by the total number of visits (20), and then multiplying by 100%. The outcome is expressed as the mean percent response in each treatment group. The Kolmogorov-Smirnov method was used to compare the treatment groups.
Measured: Week 6 to Week 25
Cumulative Response Rate - Drug Test for Illicit Use of Opioids
The cumulative response rate for the illicit use of opioids was calculated from Week 6 to Week 25 of treatment. Response was defined as the presence of a negative urine drug test for opioids at a study visit. The cumulative response rate from Week 6 to Week 25 is calculated by dividing the number of responses from Week 6 to Week 25 by the total number of visits (20), and then multiplying by 100%. The outcome is expressed as the mean percent response in each treatment group. The Kolmogorov-Smirnov method was used to compare the treatment groups.
Measured: Week 6 to Week 25
Cumulative Response Rate - Self-reports of Illicit Use of Opioids
The cumulative response rate was calculated from Week 6 to Week 25 of treatment. Response was defined as the presence of a negative self-report for illicit use of opioids at a study visit. The cumulative response rate from Week 6 to Week 25 is calculated by dividing the number of responses from Week 6 to Week 25 by the total number of visits (20) and then multiplying by 100%. The outcome is expressed as the mean percent response in each treatment group. The Kolmogorov-Smirnov method was used to compare the treatment groups.
Measured: Week 6 to Week 25
Percentage of Subjects Abstinent
Abstinence is defined as a subject having urine drug tests negative for opioids as well as self-reports negative for illicit use of opioids at Week 25. Positive urine drug tests or positive timeline followback (TLFB) qualified as not abstinent. Each subject was scored as abstinent or non-abstinent and the groups were compared using a chi-squared test.
Measured: Week 25
Proportion of Subjects Completing the Study
A study completer was defined as a subject who completed either the urine drug screen (UDS) or the self-report assessment at the Week 25 visit. The endpoint completion rate differs from the disposition completion rate because the disposition rate used the study completion definition instead of the UDS or self-report assessment at the Week 25 visit.
Measured: Week 25
Global Clinical Impression - Severity
Clinical global Impression - severity - The severity of opioid dependence was assessed at Week 13 and Week 25 using the following assessment scale:
Considering your total clinical experience with this particular population, how mentally ill is the subject at this time?
0 = Not assessed
- = Normal, not at all ill
- = Borderline ill
- = Mildly ill
- = Moderately ill
- = Markedly ill
- = Severely ill
- = Among the most extremely ill subjects
Measured: Week 13 and Week 25
Clinical Global Impression - Improvement
Clinical global impression - improvement - Improvement in severity of opioid dependence from baseline (study Day 1) was assessed by the Investigator at the visit on Week 13 and Week 25 using the following assessment scale:
Rate total improvement whether or not, in your judgement, it is due entirely to drug treatment. Compared to his or her condition at admission to the project, how much has the subject changed?
0 = Not assessed
- = Very much improved
- = Much improved
- = Minimally improved
- = No change
- = Minimally worse
- = Much worse
- = Very much worse
Measured: Week 13 and Week 25
Opioid Cravings - Change From Baseline
Cravings for opioids were assessed by the subject through the use of a visual analog scale (VAS), where 0 mm represents "no cravings" and 100 mm represents "the most intensive craving I have ever had". The baseline craving VAS assessment was collected on study Day 1 and subsequent assessments were collected at the visit on Weeks 5, 9, 13, 17, 21, and 25.
Measured: Day 1 (baseline) and Weeks 5, 9, 13, 17, 21 and 25.
Cumulative Response Rate - Illicit Non-opioid Drugs of Abuse
The cumulative response rate was calculated from Week 6 to Week 25 of treatment. Response was defined as the presence of both a negative urine drug test for opioids and a negative self-report for illicit use of non-opioid drugs of abuse at a study visit. The cumulative response rate from Week 6 to Week 25 is calculated by dividing the number of responses from Week 6 to Week 25 by the total number of visits (20) and then multiplying by 100%. The outcome is expressed as the mean percent response in each treatment group. The Kolmogorov-Smirnov method was used to compare the treatment groups.
Measured: Week 6 to Week 25
Resource Use - Number of Hospitalizations
Number of subject hospitalizations weeks 1-25.
Measured: Weeks 1-25
Resume Productive Activity
Subjects were asked if they were able to resume work, school, or other productive activities. The possible responses were Yes, No, and No Change. Only subjects with non-missing data in each group were included in the analysis.
Measured: Week 25
Resource Use - Emergency Department Visits
Number of subject emergency department visits weeks 1-25.
Measured: Weeks 1-25
Overdose Events
Overdose events
Measured: Weeks 1-25
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2021
- Study start30 Jun 2021
- Primary completion12 Apr 2023
- Study completion10 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Opioid-use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 437 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orexo AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Capano, PharmD, Study director, Orexo US, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04948307
- Sponsor's protocol ID
- OXD01-001
- Status last verified
- Jun 2025
- First submitted
- 22 Jun 2021
- Last updated
- 27 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Parallel-group Study to Evaluate the Efficacy of the Digital Therapeutic OXD01 (MODIA™) in Combination With Sublingual Buprenorphine/Naloxone for the Treatment of Opioid Use Disorder
- ClinicalTrials.gov ID
- NCT04948307
- Acronym / sponsor ID
- OXD01-001
- Conditions
- Opioid-use Disorder
- Keywords
- digital therapy, cognitive behavioral therapy (CBT)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 437 participants (actual)
- Lead sponsor
- Orexo ABIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2021 (actual)
- Primary completion
- 12 Apr 2023 (actual)
- Study completion
- 10 May 2023 (actual)
- First posted
- 1 Jul 2021 (actual)
- Results
- Posted 27 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, randomized, parallel-group multicenter study designed to evaluate the efficacy of the digital therapeutic OXD01 (MODIA) combined with sublingual buprenorphine/naloxone standard of care (SL BUP/NAL SOC) background therapy compared to SL BUP/NAL alone to change opioid use patterns in subjects with opioid use disorder (OUD).
Approximately 400 subjects will be randomized. The study will include a screening visit and a randomization visit, followed by 24 weeks of study treatment. Subjects will be scheduled for evaluation visits, which will include a urine drug screen (UDS) and a self-report of drug use, weekly during the first four weeks of treatment, then every other week from weeks 5 through 12, then monthly through week 25. Subjects will also return to the site for only a UDS and a self-report of drug use each week between the evaluation visits.
The primary objective of the study is to determine whether the combination of sublingual (SL) buprenorphine/naloxone (BUP/NAL) standard of care (SOC) background therapy and the digital therapeutic OXD01 is superior to SL BUP/NAL alone to reduce opioid use.
Detailed description
Medication-assisted treatment, the current standard for opioid addiction, is the use of medications in combination with counseling and behavioral therapies to provide a "whole-patient" approach to the treatment of OUD. However, patients may not have optimal access to face-to-face clinical behavioral health services. Digital therapeutics can help bridge the gap between accessible services and optimal treatment of OUD, the primary goal of which is to reduce the use of opioids. OXD01 is a device-based digital therapeutic, designed to offer individuals diagnosed with OUD quality psychotherapy intervention based on cognitive behavioral therapy and motivational interviewing. This study is being conducted to determine the value of OXD01 when combined with medication to change opioid use patterns in subjects with OUD.
Note: No investigational product will be administered as part of this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sublingual buprenorphine/naloxone (SL BUP/NAL) standard of care (SOC) background therapy | Other | Other: Standard of CareStandard of care. Subjects in both groups will receive the assigned treatment for 24 weeks. Subjects in both groups may also be encouraged to participate in behavioral health therapies in accordance with the Investigator's standard of practice. |
| Sublingual buprenorphine/naloxone (SL BUP/NAL) + OXD01 | Experimental | Device: OXD01 digital therapy, Other: Standard of CareStandard of care + OXD01 (digital therapy). Subjects in both groups will receive the assigned treatment for 24 weeks. Subjects in both groups may also be encouraged to participate in behavioral health therapies in accordance with the Investigator's standard of practice. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female 18 - 65 years of age at the screening visit, fluent in English and able to read, comprehend, and willingly sign the informed consent form (ICF).
- Voluntarily seeking treatment for OUD.
- In the judgment of the Investigator has the appropriate hearing, vision, manual dexterity, ability to understand instructions, and ability to use and understand internet-based applications.
- Currently meets the criteria for moderate or severe opioid use disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM)-V (Appendix B).
- Has a positive UDS for opioids at screening that is consistent with their drug use history.
Key exclusion criteria (14 listed)
- 1. Unwilling or unable to comply with the requirements of the protocol or are in a situation or condition that, in the opinion of an Investigator, may interfere with participation in the study (e.g., does not have reliable internet access).
- 2. History of allergy or sensitivity to naloxone, buprenorphine or other opioids, or history of any drug hypersensitivity or intolerance which, in the opinion of an Investigator, would compromise the safety of the subject.
- 3. Used an investigational drug within 30 days or 5 half-lives (whichever is greater) prior to randomization.
- 4. Received prescribed medication-assisted treatment with buprenorphine, methadone, or naltrexone for opioid use disorder within 14 days prior to screening.
- 5. Past or present diseases that, judged by an Investigator and based on available medical history/records, may jeopardize the safety of the subject or impact the validity of the study results.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OXD01 digital therapyOXD01 digital therapy, 1-2 times per week 15-30 minutes each time. | Device | Sublingual buprenorphine/naloxone (SL BUP/NAL) + OXD01 |
| Standard of CareSublingual buprenorphine/naloxone Medication-assisted treatment, the current standard for opioid addiction; the use of medications in combination with counseling | Other | Sublingual buprenorphine/naloxone (SL BUP/NAL) + OXD01, Sublingual buprenorphine/naloxone (SL BUP/NAL) standard of care (SOC) background therapy |
Primary outcome
Treatment Success Rate
Time frame: Week 6 to Week 25
The primary objective was to determine whether the combination of sublingual buprenorphine/naloxone (SL BUP/NAL) and OXD01 was superior to SL BUP/NAL alone to reduce opioid use, measured by the treatment success rate. Treatment success was defined as the subject having >/=80% of urine drug tests negative for opioids plus >/=80% of self-reports negative for illicit opioid use from Week 6 to Week 25. Each subject was evaluated as a success or failure for this metric. The percentage of subjects in each group demonstrating treatment success was tested using the Chi-square test. If the subject withdrew from the study, the urine drug tests and self-reports for illicit opioid use for all visits after withdrawal were imputed as positive. If the subject completed the study with missing visits, the missing urine drug tests and self-reports for illicit opioids were imputed as positive.
13 secondary outcomes
Cumulative Response Rate
Time frame: Week 6 to Week 25
Cumulative Response Rate - Drug Test for Illicit Use of Opioids
Time frame: Week 6 to Week 25
Cumulative Response Rate - Self-reports of Illicit Use of Opioids
Time frame: Week 6 to Week 25
Percentage of Subjects Abstinent
Time frame: Week 25
Proportion of Subjects Completing the Study
Time frame: Week 25
Global Clinical Impression - Severity
Time frame: Week 13 and Week 25
Clinical Global Impression - Improvement
Time frame: Week 13 and Week 25
Opioid Cravings - Change From Baseline
Time frame: Day 1 (baseline) and Weeks 5, 9, 13, 17, 21 and 25.
Cumulative Response Rate - Illicit Non-opioid Drugs of Abuse
Time frame: Week 6 to Week 25
Resource Use - Number of Hospitalizations
Time frame: Weeks 1-25
Resume Productive Activity
Time frame: Week 25
Resource Use - Emergency Department Visits
Time frame: Weeks 1-25
Overdose Events
Time frame: Weeks 1-25
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Capano, PharmD study director
Orexo US, Inc.
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OXD01 digital therapy in people with Opioid-use Disorder, run by Orexo AB at 21 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Success Rate (time frame: Week 6 to Week 25). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2025.